UMIN-CTR Clinical Trial

Basic information
Public title	A prospective study to explore the relationship between SPARC expression and efficacy of nab-paclitaxel as second-line chemotherapy for advanced gastric cancer (SYNAPSE study)
Acronym	A prospective study to explore the relationship between SPARC expression and efficacy of nab-paclitaxel as second-line chemotherapy for advanced gastric cancer (SYNAPSE study)
Scientific Title	A prospective study to explore the relationship between SPARC expression and efficacy of nab-paclitaxel as second-line chemotherapy for advanced gastric cancer (SYNAPSE study)
Scientific Title:Acronym	A prospective study to explore the relationship between SPARC expression and efficacy of nab-paclitaxel as second-line chemotherapy for advanced gastric cancer (SYNAPSE study)
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the correlation between the expression of SPARC and the efficacy of nab-paclitaxel as second-line chemotherapy for metastatic or recurrent gastric cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Overall Survival according to SPARC expression
Key secondary outcomes	Progression Free Survival Time to Treatment Failure Response Rate Disease Control Rate Dose Intensity Adverse Event Clinicopathological Characteristics of SPARC expression

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	nab-paclitaxel
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histlogically confirmed gastric adenocarcinoma 2) Unresectable or recurrent gastric cancer 3) No previous chemotherapy for other malignancies 4) Prior chemotherapy consisted of fluoropyrimidine for unresectable or reccurent gastric cancer 5) No past history of treatment related taxan 6) Age : 20 years old and more 7) ECOG Performance Status 0-2 8) Liffe expectancy : 90 days and more 9) Adequate organ function as evidenced by the follow laboratory studies within 28 days prior to enrollment a)Neutrophil conunt : 1,500 /mm3 or above b)Platet count : 100,000 /mm3 or above c) Hemoglobin : 8.0 g/dL or above d) Total bilirubin : 1.5 mg/dL or less e) AST(GOT) : 100 IU/L or less (200 IU/L or less in patients with liver metastasis) f) ALT(GPT) : 100 IU/L or less (200 IU/L or less in patients with liver metastasis) g) Serum creatinine : 1.5 mg/dL or less 10) Tumor tissue can be used for this study 11) Written informed consent
Key exclusion criteria	1) Multiple primary cancers with disease-free period less than 5-years, except carcinoma in situ or intra mucosal disease cured by local therapy 2) Past history of severe hypersensitivity to drug 3) Active incection 4) Fever more than 38 degree 5) Central nervous system metastasis or carcinomatous meningitis 6) Massive cardiac effusion, pleural effusion or ascites 7) Peripheral sensory neuropathy : grade 2 or above (CTCAE v4.0) 8) Chronic daily treatment with oral or intravenous corticosteroids 9) Unstable angina or past history of myocardinal infraction in 6 months 10) Evidence of any other serious disease ; renal failure, hepatic failure, interstinal pneumonitis or lung fibrosis 11) Pregnant, lactating female, female of childbearing potential or male without contracepcion intention 12) Psychiatric disease that is inapprocpriate for entry into this study 13) Any patients judged by the investigator to be unfit to participate in the study
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kentaro Yamashita
Organization	Sapporo Medical University
Division name	Department of Gastroenterology, Rheumatology and Clinical Immunology
Zip code
Address	South 1 West 16, Chuo-ku, Sapporo, 060-8543, Japan
TEL	+81-11-611-2111
Email	ykentaro@sapmed.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kei Onodera
Organization	Sapporo Medical University
Division name	Department of Gastroenterology, Rheumatology and Clinical Immunology
Zip code
Address	South 1 West 16, Chuo-ku, Sapporo, 060-8543, Japan
TEL	+81-11-611-2111
Homepage URL
Email	konodera@sapmed.ac.jp

Sponsor
Institute	Department of Gastroenterology, Rheumatology and Clinical Immunology, Sapporo Medical University
Institute
Department

Funding Source
Organization	Department of Gastroenterology, Rheumatology and Clinical Immunology, Sapporo Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 08 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 06 Month 06 Day
Date of IRB	2014 Year 06 Month 06 Day
Anticipated trial start date	2014 Year 08 Month 08 Day
Last follow-up date	2020 Year 11 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 08 Month 07 Day
Last modified on	2020 Year 11 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017195